MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AURALIS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 636009

Device Problem Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion has not been formulated yet.Once the investigation is completed a final report will be submitted,.

Event Description

A customer reported a power issue with an auralis pump.The customer reported that when they plugged in the pump, the power tripped.The nurses did not notice the damage on the cable and kept trying to plug in the power cord couple of times.Each time the power tripped.The technician who visited the customer to evaluate the product, found that the power cord was damaged, the isolation was ripped off, exposing internal cooper wires.The power cord was crashed since it stuck under the bed¿s wheel.The technician replaced the pump.

Manufacturer Narrative

The customer reported that they moved the patient to room from another room and when they plugged in the auralis pump, the power tripped.The nurses did not notice the damage on the cable and kept trying to plug in the power cable couple of times.Each time the power tripped.The technician who visited the customer to evaluate the product, found that the power cord was damaged, the insulation was ripped off, exposing internal cooper wires.The power cable was crashed since it stuck under the bed¿s wheel.The technician replaced the pump.The technician observed that the power cable was not secured since the cable management was not used and the power cable was handling from the bed when moving the bed from one room to another.Auralis instruction for use (ifu) 4.Ai.00_1en dated 07/2019 includes the following guidance and warning in regards to the power cable."position the power cable in the cable management on the left side of the auralis mattress" "to avoid falling and injury, make sure that cables and the tube-set are positioned correctly and are clear of moving bed mechanisms or other possible entrapment areas".This document also describes and provides graphical images showing the cable management and instruction on how the power cord shall be positioned using the cable management.In the care and preventive maintenance schedule, the documents points out to the caregivers obligation, which includes checking the power cord for wear or damage, before every use or every week (if for long term use) and if any part is damaged the product cannot be used.In the reported complaint, despite the power cable being damaged, the user kept trying to plug in to the socket, most likely not realizing that the problem with power tripping was related to the power cable being damaged, which would indicate that the power cable was not checked, after the bed was moved from one room to another.When the event occurred, the device being used for treatment, therefore it was involved in the reported event.The product failed to meet its specifications, since the power cable became damaged from use error.This complaint is deemed reportable because the power cable was not excluded from use, but despite it was damaged the staff kept using it (plugging it to the power socket several times), which could lead to a potential hazard, such as electrical shock.No serious injury was sustained in this complaint.

• Brand Name: AURALIS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16562904
• MDR Text Key: 311499376
• Report Number: 3005619970-2023-00005
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675334
• UDI-Public: (01)05056341675334(11)200405
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female